The Challenge Faced
- Critical gaps identified as a results of corporate audit
- Computer system validation program needed development
- Lack of process for SDLC, SOP and templates
- Due to resource constraints a CSV department was not an option
- Requirement to implement a new process without adding new resources
PharmAllies’ Deliverables
- Trained the SLT, engineering & validation departments on QRM (ICH-Q9)
- Risk-based validation program implemented
- 21 new and updated SOPs created
- 12 new forms created
- Computer System Validation SDLC implemented
- Developed template for URS, FRS, RA, DDS, VPP, TM, IQ/OQ/PQ, and VSR
- Wonderware Building Management System (BMS) installation and risk-based validation
Assessment
A corporate audit identified critical gaps in a global pharmaceutical company’s validation and standardization processes. Some concerns raised included the lack of computer system validation programs as well as the lack of definitive process for their SDLC and standard operating procedures. A proposed solution was to create a computer system validation (CSV) department, however, due to resource constraints, this was not practical.
PharmAllies trained the engineering and validation departments on quantitative risk management (QRM) under the ICH-Q9 guidelines. Our company was able to implement a risk-based validation program that included the creation of 21 new and updated SOPs as well as 12 new forms. In addition, PharmAllies also developed templates for URS, FRS, RA DDS, VPP, TM, IQ/OQ/PQ, and VSR. Wonderware Building Management System (BMS) was also installed.
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